BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUT SURGICAL SUTURE

    MDR report key: 3190980 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-07516
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAL
    PMA / PMN Number
    N10389
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE EVALUATION FOUND A HAIR STRAND THAT CROSSES THE SEALING REGION OF THE ENVELOPE. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIOR TO USING ON THE PATIENT, A STRAND OF HAIR WAS FOUND INSIDE THE SEALED PACKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290522 GUT SURGICAL SUTURE SUTURE, ABSORBABLE GAL ETHICON, INC. NA 417061

    Patients

    Seq Age Sex Outcome Treatment
    1